Essentials in Minimally Invasive Gynecology Manual Skills Pilot Validation Trial.

STUDY OBJECTIVE: To evaluate the Essentials in Minimally Invasive Gynecology (EMIG)- Fundamentals of Laparoscopic Surgery Laparoscopic Simulation System and the EMIG Hysteroscopy Simulation System for face validity and functionality in a pilot testing environment. DESIGN: A prospective controlled pilot study. SETTING: Three teaching institutions in the US Southwest. SUBJECTS: Twenty-seven residents and gynecologists, with 22 fitting who fit 1 of 4 categories of exposure to hysteroscopic and laparoscopic surgery and surgical simulation. Eleven were postgraduate year 1 and 5 postgraduate year 3, 1 was American Board of Obstetrics & Gynecology certified, and 5 were either fellows in-training or had completed a fellowship in minimally invasive gynecologic surgery. INTERVENTIONS: After completing a screening survey, each subject was exposed to a structured orientation to the 2 simulation systems and then tested with proctor supervision on the 5 laparoscopic and 2 hysteroscopic exercises. A short 5-point Likert questionnaire designed to determine face validation and question clarity was administered to each subject at sites 2 and 3. MEASUREMENTS AND MAIN RESULTS: Face validity was high for each of the 7 exercises (means ranged from 4.8 to 4.9 of 5), and subjects considered instructions to be clear (means from 4.7 to 4.9). The recorded exercise times generally reduced with increasing levels of training, although the sample sizes were not designed to determine significance given the pilot design. Similarly, exercise errors were generally less frequent with increasing experience. The systems, including the devices and recording mechanisms, performed well, and proctor evaluation and training were satisfactory. CONCLUSION: The EMIG laparoscopic and hysteroscopic simulations systems were considered to have good face validity and appear to be suitable for a construct validation trial to confirm their utility in distinguishing among trainees and practitioners with a wide spectrum of endoscopic surgical experience. The recording and specimen storage mechanisms will allow for multiple proctors to rate a candidate's performance, thereby enhancing evaluation consistency and quality.

Cosmetic Surgery-Use of 3mm Ports and Reduced-Port Techniques for Gynecologic Surgery.

As innovation continues to evolve in gynecologic surgery, new "cosmetic" techniques are continually being developed. Minimally invasive surgery offers clear benefits over open surgery, such as decreased postoperative pain, infection, length of hospital stay, and time out of work. It is now possible to perform many laparoscopic gynecologic surgeries with minimal to no visible scars. This article reviews the use of 3mm ports and several reduced-port and single-port techniques for use in gynecologic surgery as well as vaginal natural orifice transluminal endoscopic surgery (vNOTES). We also discuss the advantages and challenges that physicians face regarding the adoption of these procedures into general practice. Lastly, we present our novel economic adaption in approach to reduced-port laparoscopic bilateral salpingectomy versus traditional single-site laparoscopic bilateral salpingectomy. In conclusion, minimally invasive approaches to gynecological surgery are considered feasible and safe.

Comparative Thermal Effects of J-Plasma®, Monopolar, Argon, and Laser Electrosurgery in a Porcine Tissue Model.

INTRODUCTION: The objective of this study was to understand how J-Plasma® (Bovie Medical Corporation, Clearwater, Florida) surgical energy compares to monopolar, argon beam, and CO2 laser devices in terms of depth of penetration and lateral thermal spread in a porcine tissue model. MATERIALS AND METHODS: Using a porcine animal model, we applied the thermal energy of the J-Plasma® laser, Bovie Monopolar Pencil™ (Bovie Medical Corporation, Clearwater, Florida), argon beam coagulator, and CO2 laser to porcine small bowel, bladder, and peritoneal tissues at equivalent settings. Tissue was excised and sent to pathology for histologic evaluation. Primary outcome was depth of penetration and lateral thermal spread. RESULTS: When applied to peritoneum tissue, CO2 laser had the greatest lateral thermal spread at 2.99mm, while the argon beam had the lowest at just under 1.5mm. With regard to depth of penetration, the monopolar pencil had the highest while J-Plasma® had the lowest. When applied to bladder tissue, the argon beam was associated with the greatest lateral thermal spread (3.1mm) as compared to the other three devices (all less than 1mm). In terms of depth of penetration of bladder tissue, J-Plasma® again had the lowest value, while the monopolar pencil had the highest. When applied to small intestine tissue, the argon beam had the greatest lateral spread (3.51mm), while J-Plasma® had the lowest (less than 1mm). Regarding depth of penetration of small intestine tissue, argon beam had the highest value at 1.8mm compared to the other three devices (all below 0.6mm). CONCLUSION: Consistent with our previous study, J-Plasma® had minimal lateral and depth spread when applied to various tissue types. J-Plasma® performed better or similar when compared to monopolar, argon beam, and laser electrosurgical devices. Further studies in-vivo are needed to evaluate safety and surgical application of the J-Plasma® device.

Intrauterine Pressure During Hysteroscopic Morcellation: A Comparison of Three Commercially-Available Devices.

STUDY OBJECTIVE: Our objective was to compare intrauterine pressures during resection and aspiration modes among three types of commercially-available hysteroscopic morcellators. DESIGN: This was a benchtop study (Canadian Task Force level II-1). This study cannot feasibly and ethically be done in-vivo, so an ex-vivo study design was chosen. SETTING: A silicone uterine model was attached to a manometer via tubing, with the tip inside the cavity to allow for intracavity pressure measurements. Each hysteroscopic morcellator was then introduced, and intracavity pressures were recorded every one to two seconds in three modes (static, resection, and aspiration) and at three set point pressures (45, 85, and 125 mmHg). PATIENTS: No human subjects were involved in this study. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: There were a total of 4,872 pressure measurements during this study across the three devices, over the three modes, and at the three set point pressures combined. Using mixed-effects linear regression, the mean observed intracavity pressure was not greater than the set pressure for each of the three devices. This result held true in both aspiration and resection modes. In our statistical models, the coefficient on the terms representing the interaction between device and time were not statistically significant in either resection or aspiration modes. This indicates that, statistically, the change in intracavity pressure over time was not significantly different across the three devices. CONCLUSION: In this first of its kind head-to-head benchtop study, we found that all three commercially-available hysteroscopic morcellators appear to be similar to each other in terms of their abilities to maintain intracavity pressure below the set pressure, which is important in avoiding intravasation in-vivo. These findings are important because many gynecologists do not have the ability to choose between the three available devices on the market at their institution.

Developing a visual aid to improve women's knowledge of hysterectomy.

BACKGROUND: Female reproductive anatomy and physiology, compounded by low health literacy, can result in limited patient understanding of gynecologic procedures, complicating the already challenging patient decision-making process. OBJECTIVE: Describe a process of developing an effective visual aid that accurately communicates the risks, benefits, and possible outcomes of hysterectomy surgical approaches. PATIENT INVOLVEMENT: None. METHODS: This qualitative study was performed in a private practice and an academic institution with a total of 8 female non-clinical employees in the English-speaking group and 9 non-employees in the Spanish-speaking group. A 5-minute video focusing on the hysterectomy procedure was developed and shown to focus group participants. A discussion led by a sociologist obtained feedback regarding understanding and perceptions of video content to validate the tool, which was analyzed to extract themes that could guide refinements. RESULTS: Focus group participants wanted more information on post-hysterectomy quality of life and desired a longer video that included more general information about hysterectomies. All participants felt the video would be a valuable aid if watched prior to undergoing a hysterectomy and would be an effective tool for improving patient communication. DISCUSSION: While there was strong support for the video-based patient education program, participants found some elements confusing (e.g., type and magnitude of risk, scope of aftercare) and expressed interest in more in-depth information. Our development process would have been enhanced by involving patients before the initial version of the video was created, holding more and more diverse focus groups and ensuring that translation was both accurate and culturally appropriate. PRACTICAL VALUE: This study offers lessons learned in the process of developing a video-based visual aid for improving women's knowledge of hysterectomy and may inform other efforts to help patients understand complex medical pathology and procedures.

Patient Understanding of Uterine Fibroids and the Different Surgical Approaches to Hysterectomy.

Objective: The purpose of this study was to assess understanding of the hysterectomy procedure and uterine fibroids among women in a general gynecology clinic. Materials and Methods: This was an anonymous cross-sectional survey. We adapted and pilot tested a survey instrument designed to assess understanding of the hysterectomy procedure and of uterine fibroids. The final version of the survey consisted of basic demographic questions, followed by 28 knowledge questions (Canadian Task Force Classification II-2). The survey was disseminated to women in the waiting room of one of our gynecology clinics. The patient population included women 18 years and older. Results: The mean age of respondents was 33.5 years old. In total, 69.5% of the respondents had at least some college education. In the group of questions related to different types of hysterectomies, the most poorly answered question was "Which type of hysterectomy has the highest risk of damage to the bladder?" Less than 40% of the respondents were able to identify a laparoscopic and robotic hysterectomy based on a written description. Of questions about uterine fibroids, the most poorly answered question was whether cancer that looks like fibroids is common, with >90% of the respondents incorrectly thinking that cancer that resembled fibroids is common. More than half of respondents did not know what a fibroid is. Conclusions: In this analysis of the understanding of the hysterectomy procedure and fibroids among an educated population, overall understanding was poor. Specific areas where knowledge was particularly poor were the different ways of doing a hysterectomy and uterine fibroids.

Enhanced Recovery Program and Length of Stay After Laparotomy on a Gynecologic Oncology Service: A Randomized Controlled Trial.

OBJECTIVE: To estimate whether a rapid recovery program would reduce length of stay among patients undergoing laparotomy on a gynecologic oncology service. METHODS: We conducted a prospective, randomized, controlled trial comparing an enhanced recovery after surgery protocol with routine postoperative care among women undergoing laparotomy on the gynecologic oncology service. Protocol elements included: preoperative counseling, regional anesthesia, intraoperative fluid restriction, and early postoperative ambulation and feeding. A sample size of 50 per group (N=100) was planned to achieve 80% power to detect a two-day difference in our primary outcome, length of hospital stay; secondary outcomes included: total daily narcotics used, time to postoperative milestones, and complications. RESULTS: A total of 112 women were enrolled between 2013 and 2015. Nine patients did not undergo laparotomy and were excluded, leaving 52 and 51 patients in the control and intervention groups, respectively. There was no difference in length of stay between the two groups (median 3.0 in both groups; P=.36). Enhanced recovery after surgery patients used less narcotics on day 0 (10.0 compared with 5.5 morphine equivalents in the control and intervention arms, respectively, P=.09) and day 2 (10.0 compared with 7.5 morphine equivalents, respectively; P=.05); however, there was no statistically significant difference between groups in any of the secondary outcomes. Post hoc analysis based on actual anesthesia received also failed to demonstrate a difference in time to discharge. CONCLUSION: When compared with usual care, introducing a formal enhanced recovery after surgery protocol did not significantly reduce length of stay. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01705288.